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Dosage form: & nbspLyophilizate for solution for infusion.
Composition:

1 bottle contains:

Active substances:

Thiamine mono nitrate 3.1 mg

(eqv. thiamine [vitamin B1] 2.5 mg)

> Riboflavin sodium phosphate dihydrate 4.9 mg

(eq. riboflavin [vitamin B2] 3.6 mg)

Nicotinamide 40 mg

Pyridoxine hydrochloride 4.9 mg

(eq. pyridoxine [vitamin B6] 4.0 mg)

Sodium pantothenate 16.5 mg

(eq. acid pantothenic acid 15 mg)

Sodium ascorbate 113 mg

(eqv ascorbic acid, [vitamin C] 100 mg)

Biotin 60 μg

Folic acid 0.40 mg

Cyanocobalamin 5.0 μg

Excipients:-

Glycine 300 mg

Disodium edetate 0.5 mg

Methylparahydroxybenzoate 0.5 mg

Description:Freeze-dried compressed powder of yellow color.
Pharmacotherapeutic group:Multivitamins (parenteral administration).
Pharmacodynamics:Soluvit N. is a libidified sterile powder containing water-soluble vitamins. It is used together with infusion solutions for intravenous administration and provides a daily requirement for water-soluble vitamins in children and adults.
Indications:
It is used as an integral part of complete parenteral nutrition to meet the daily requirement for water-soluble vitamins in children and adults.
Contraindications:Hypersensitivity to any ingredient in the drug in history.
Dosing and Administration:
Soluvite H must be dissolved in aseptic conditions immediately before use.
Adults and children over 11 years of age
The contents of one vial under aseptic conditions are dissolved in 10 ml of one of the following solutions:
1. Vitalipid H adult
2. Intralipid (10% or 20%)
3. Water for injections
4. Glucose solutions (5%, 10%, 20%)
The contents of the vial after dissolving in 10 ml of Vitalipid or Intralipid under aseptic conditions are added to the fat emulsion (for example, Intralipid), or to the system for parenteral nutrition "three in one" (Kabiven central and peripheral).
A solution obtained by dissolving Soluvite H in 10 ml of water for injection or a solution of glucose is added under aseptic conditions to glucose solutions (5%, 10%, 20%), fat emulsion (for example, Intralipid), or to the parenteral nutrition system " three in one "(for example, Kabiven central or Kabiven peripheral).
The contents of one bottle satisfy the daily requirement for vitamins. Adults and children over 11 years of age should receive 1 bottle per day.
Children under 11 years of age
The contents of one vial under aseptic conditions are dissolved by adding 10 ml of one of the following solutions:
1. Vitalipid N Children's
2. Intralipid (10% or 20%)
3. Water for injections
4. Glucose solutions (5%, 10%, 20%)
The contents of the vial after dissolution in 10 ml of Vitalipid or Intralipid under aseptic conditions are added to the fat emulsion (Intralipid), or to the system for parenteral nutrition "three in one" (Kabiven central and peripheral):
A solution obtained by dissolving Soluvit H in 10 water for injection or a glucose solution is added under aseptic conditions to glucose solutions (5%, 10%, 20%), fat emulsion (Intralipid), or to a parenteral nutrition system "three in one "(Kabiven is central and peripheral).
Children weighing less than 10 kg: with the addition of 10 ml of compatible solution to the bottle with Soluvite H, the daily requirement for water-soluble vitamins provides 1 ml of the resulting solution per 1 kg of body weight. Newborns and children weighing less than 10 kg should receive 1/10 of the contents of the bottle (1 ml of the solution obtained) per 1 kg of body weight per day.
Side effects:On the background of Soluvite H infusion, allergic reactions may be observed in patients with a hypersensitivity to any component of the drug in the history, for example, to thiamine or methyl parahydroxybenzoate.
Interaction:
Pyridoxine (vitamin Bb) can reduce the effect of levodopa.
Folic acid can reduce the concentration of phenytoin in the serum. In addition, the administration of folic acid in large doses can make it difficult to diagnose pernicious anemia.
Special instructions:
Soluvite H must be dissolved immediately before use.
Soluvite H solution must be added under aseptic conditions to the infusion solution immediately before the infusion and used within 24 hours.
When diluting Soluvite H in aqueous solutions, the mixture must be protected from light. When Soluvit H is diluted in Intralipida, this is not necessary, since the fat emulsion has light-protective properties.
Form release / dosage:
Lyophilizate for solution for infusion.
Packaging:
In a bottle of colorless glass, corked with a rubber stopper and an aluminum cap under the running-in, from above with a closed plastic cap-control the first opening.
For 10 vials in a contour acheive box are placed in a cardboard pack together with the instruction for use.
Storage conditions:
Store at a temperature of no higher than 25 ° C in a dark place.
Keep out of the reach of children.
Shelf life:30 months.Do not use after expiry date.
Terms of leave from pharmacies:On prescription
Registration number:P N008333
Date of registration:27.01.2010
The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
Manufacturer: & nbsp
Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
Information update date: & nbsp17.02.2016
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